IVW: Pandemic Vaccines May be Too Little, Too Late

CANNES, France, April 28 -- If the swine flu outbreak develops into a pandemic -- and that's a big if -- the earliest the public would see a vaccine against the disease would be September, a researcher said here at the conference on Influenza Vaccines for the World.

And that's if the government asks industry to start production today, said Klaus Stohr, D.V.M., vice president and global head of Novartis Vaccines and Diagnostics and former head of the World Health Organization's global influenza program.

"What we have seen the last two or three days is that the current pandemic vaccine system is not ideal not only in terms of timing . . . but also in terms of vaccine production," he said.

Any hopes that the version of H1N1 in the current seasonal vaccine would provide protection against the swine flu seemed to be dashed by preliminary data from Novartis-run tests.

Dr. Stohr said the findings suggested the H1N1 viruses contained in seasonal vaccines all the way back to 1980 are more closely related to each other than any are to the new virus, although he cautioned that more study was needed before concluding that there wouldn't be cross-protection.

He said that the outbreak of swine influenza A H1N1 has not changed "the assessment that pandemic vaccines are too little, too late, and that they are not going to be a solution even for countries that have domestic vaccine production."

Based on the current state of the swine flu investigation -- ongoing clinical, epidemiological, and virological studies -- it would take about two weeks for vaccine strain preparation, he said.

Seed virus preparation would take another three or four weeks, putting the start of bulk production at the end of June, Dr. Stohr said.

Standardizing reagents would not be available for another eight weeks, and quality control would tack on an additional one to two, he said.

Only then, in early September, would Novartis and other vaccine makers start distributing vaccine, he said.

Any decisions regarding pandemic vaccine production, he said, are complicated by the fact that nobody knows whether the virus will cause a pandemic, become endemic in humans causing continuous small outbreaks, or fizzle out and disappear.

If the virus were to "disappear" though, that would not necessarily eliminate the need to prepare for its re-emergence if it remained in an animal reservoir, Dr. Stohr said.

A possible solution would be development of a tetravalent seasonal flu vaccine, he said.

Further complicating decision-making is the looming threat of an H5N1 avian flu pandemic.

"The absolute risk of H5N1 to cause a pandemic has not changed," he said. "It remains a strain with high pandemic potential."

Swine flu, however, has bumped it down to number two on the list, he said.

The swine flu outbreak serves as "a stark reminder of the unpredictability of the timing and of the speed by which the pandemic situation can change," he said.

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